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WADA’s Therapeutic Use Exemption program – providing inclusion and fairness for athletes

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In this latest edition of ‘Spotlight’, which keeps stakeholders up to date on the activities being carried out by the World Anti-Doping Agency (WADA) team and its partners, we look at the Therapeutic Use Exemption (TUE) program. This program provides a harmonized global approach for athletes that have illnesses or medical conditions that require them to take medications that are included on WADA’s Prohibited List. Previous ‘Spotlight’ features are available on WADA’s website.

History

TUEs – originally called Medical Exemptions – have existed since the early 1990s. The International Olympic Committee’s (IOC’s) medical commission recognized that some athletes had illnesses or medical conditions requiring the use of medications that were prohibited in sport. As the List of Prohibited Substances and Methods (List) – managed by WADA since 2004 – evolved over the years, it began to include many commonly used medications. Clear guidelines were therefore required to ensure that athletes could continue to receive the medical care they needed, without compromising their sporting careers.

As a response, WADA, which was created in 1999, drafted the International Standard for Therapeutic Use Exemptions (ISTUE) to ensure harmonized and robust rules were in place. The ISTUE was first adopted in 2004 and came into effect on 1 January 2005. It has been revised several times since then, with the most recent version entering into effect in January 2021.

TUEs in practice

TUEs are special exemptions that are only granted by Anti-Doping Organizations (ADOs) – International Federations (IFs), National Anti-Doping Organizations (NADOs) and Major Event Organizers (MEOs) – following a robust review process as defined by the ISTUE, and evaluation by three physicians specialized in sports medicine and/or other relevant specialties. In order to further protect the integrity of the program, granted TUEs are subject to further screening and evaluation by the relevant ADOs and experts from WADA’s Science and Medicine Department.

WADA’s Chief Medical Officer, Dr. Alan Vernec, said: “TUEs have been deemed overwhelmingly necessary by athletes, physicians and all anti-doping stakeholders. The notion of precluding athletes that suffer from illnesses and conditions such as diabetes, asthma, inflammatory bowel disease, rheumatological conditions, etc. from sport cannot be given serious consideration. It would undermine a fundamental value of sport that is the right of access and participation to sport and play, which has long been recognized by numerous international conventions.”

All athletes that compete in sport at the international level (as defined by each IF) or the national level (as defined by each NADO) can apply for a TUE. The criteria for granting a TUE are as follows:

  1. The athlete needs to treat a diagnosed medical condition with a substance or method that is on the Prohibited List;  
  2. The therapeutic use of the substance or method would not produce any additional enhancement of performance beyond a return to the athlete’s normal state of health;
  3. The substance or method is an indicated treatment for the medical condition, and there is no reasonable permitted therapeutic alternative; and
  4. The need to use the substance or method is not due to the prior use of a substance or method (without a TUE), which was prohibited at the time of such use.

For the TUE to be granted, all four criteria must be met. 

In order to ensure the harmonization of the TUE process worldwide, all ADOs are required to have a clear process in place whereby athletes with documented illnesses or medical conditions can request a TUE and have it evaluated by a panel of independent physicians called a Therapeutic Use Exemption Committee (TUEC). ADOs must publish details of that process by posting the information in a prominent place on their website. ADOs, through their TUECs, are then responsible for granting or declining the TUE request.

WADA has the mandate to monitor and review any TUE granted by an ADO. In some cases, a WADA TUEC may be convened to review and may reverse or uphold any decision. WADA may also accept a request from an athlete to review a TUE that was denied by their ADO. WADA itself, however, does not accept direct TUE applications from athletes. 

Yoko Dozono, Medical Consultant, WADA Science and Medicine said: “Our role is to monitor TUEs that are granted by an ADO and look at them from a medical perspective, ensuring that they are compliant with the ISTUE. We work closely with clinical specialists to help develop guidelines and other tools to assist athletes and their doctors in understanding the use of medications or methods in sport and when it is necessary to seek a TUE.

“Along with the ISTUE, a whole series of accompanying guidelines have been developed by WADA, our TUE Expert Advisory Group and international specialists. These include physician guidelines and checklists for the most commonly seen illnesses and medical conditions in our athlete populations.”

 

Ensuring the integrity of TUEs

There are a number of safeguards in place to ensure the integrity of the TUE program and to protect those athletes with illnesses and medical conditions. In fact, the majority of athletes needing TUEs often remain at a disadvantage because of their illness or condition despite the ability to use medications.

“We continue to monitor not just individual TUEs but the process as a whole to ensure that it is fair and not being abused”, said David Healy, Manager, WADA Science and Medicine. “We performed an in-depth review of TUEs at the highest level of sport by analyzing individual events at the Olympic Games from 2010-2018. Results showed the number of athletes competing with valid TUEs at the Games was less than 1%, which is similar to the number of medal winners with TUEs. Importantly, statistical analysis suggests that there is no meaningful association between having a TUE and winning a medal”. Photo of David

While it is true that the TUE program has a robust process, offers clear guidelines and standards, and benefits from ongoing monitoring, the key to ensuring its effective implementation by ADOs around the world is education – for athletes and their support personnel, as well as individuals within the ADOs themselves.

Katia Alloun, Medical Consultant, WADA Science and Medicine, said: “I am working with colleagues within WADA, as well as global experts, to improve the capacity and capabilities of ADOs in order to deliver harmonized and high-quality TUE programs that ensure fairness for all athletes around the world. In collaboration with WADA’s Education Department, we have developed a wide range of resources related to TUEs that athletes and ADOs can consult and use as part of their various anti-doping education programs.”

These resources can be accessed via the WADA website or WADA Anti-Doping Education and Learning platform (ADEL) and include:

  • The ISTUE and associated guidelines for implementation;
  • TUE Physician Guidelines;
  • TUE Checklists;
  • Code Implementation Support Program on ADEL – ISTUE section; and
  • Various e-learning courses and resources for athletes and medical professionals on ADEL.

For more information on the TUE program, or to access any of the resources mentioned above, please visit the TUE section of WADA’s website

The original article can be found here.

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